Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT06650163
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Glioma
  • Malignant Brain Neoplasm
  • Meningioma
  • Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Advanced Magnetic Resonance Imaging — PROCEDURE
    Undergo advanced MRI
  • Brain Surgery — PROCEDURE
    Undergo brain surgery
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Immuno-Positron Emission Tomography Scan — PROCEDURE
    Undergo immuno-PET
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Stereotactic Biopsy — PROCEDURE
    Undergo stereotactic image-guided biopsy
  • Zirconium Zr 89 Crefmirlimab Berdoxam — DIAGNOSTIC_TEST
    Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET

Study Details

This phase I trial studies how well zirconium (Zr)-89 crefmirlimab berdoxam and immuno-positron emission tomography (PET) identifies areas of immune cell activity in patients with brain tumors that can be removed by surgery (resectable). One important predictor of the immune response is the presence and change in CD8 positive (+) tumor infiltrating lymphocytes (TIL) cells. Identifying the presence and changes in CD8+ cells can be challenging, particularly for participants with central nervous system (CNS) tumors, and usually requires invasive procedures such as repeat tissue biopsies, which may not accurately represent the immune status of the entire tumor. Zr-89 crefmirlimab berdoxam is known as a radioimmunoconjugate which consists of a radiolabeled anti-CD8+ minibody whose uptake can be imaged with PET. Upon administration, Zr 89 crefmirlimab berdoxam specifically targets and binds to the CD8+ cells. This enables PET imaging and may detect CD8+ T-cell distribution and activity and may help determine the patient's response to cancer immunotherapeutic agents more accurately. Giving Zr-89 crefmirlimab berdoxam along with undergoing immuno-PET imaging may work better at identifying immune cell activity in patients with resectable brain tumors.

Key Dates

Start date
Dec 5, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
    Patients receive Zr-89 crefmirlimab berdoxam IV over 5-10 minutes 3 days prior to scheduled surgical resection. Approximately 24 hours after receiving Zr-89 crefmirlimab berdoxam, patients undergo immuno-PET scans. Patients then undergo scheduled standard of care surgical resection of the brain tumor and brain biopsy. Additionally, patients undergo advanced physiologic and metabolic MRI and MRI prior to surgery.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Sichen Li
[email protected]
310-794-5663
Robert M. Prins, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

Related Studies